Skip to main content
OpenTrials
Completed

NCT Number: NCT04064073

Study to Evaluate Drug-Drug Interaction of DWP16001 in Combination With Metformin in Healthy Male Adults (Phase 1 Study)

The purpose of this study is to evaluate drug-drug interaction of DWP16001 in combination with metformin IR 1000mg in Healthy male subjects.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Age range

19 year–50 year

Sex eligibility

Male

Study type

Interventional

Phase

Phase 1

Primary location

Seoul National University Hospital

Seoul, South Korea

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Healthy male adults aged 19 to 50 years at the time of screening test
  • 55.0 kg ≤ Body weight ≤ 90.0 kg and 18.0 ≤ Body Mass Index (BMI) ≤ 27.0
  • Written consent on voluntary decision of participation prior to the screening procedure after being fully informed of and completely understanding this study
  • Eligible to participate in the study at the discretion of the investigator by physical examination, laboratory test, and history taking, etc.

Exclusion criteria

  • Current or history of clinically significant hepatic, renal, nervous, respiratory, endocrine, hemato-oncology, cardiovascular, urogenital, psychosis disorder
  • Current or history of gastrointestinal disorders or prior history of gastrointestinal surgery that may affect safety and PK/PD assessment of the study drug
  • Hypersensitivity or medical history of clinically significant hypersensitivity to a drug containing an ingredient of the investigational product (DWP16001), Dapagliflozin, Metformin or similar ingredient or other drugs (e.g., aspirin, antibiotics, etc.)
  • Clinical laboratory test values are outside the accepted normal range at screening
  • Other exclusive inclusion criteria, as defined in the protocol

Treatment and study plan

DWP16001

Drug

Tablets, Oral, once daily single dose

Metformin IR

Drug

Metformin IR 1000mg, Tablets, Oral, BID for 7 days

DWP16001+Metformin IR

Drug

Tablets, Oral, once daily single dose DWP16001 Metformin IR 1000mg

Primary outcomes

  1. Cmax of DWP16001

    Time frame: 0-72 hours

    Peak Plasma Concetration

  2. AUClast of DWP16001

    Time frame: 0-72 hours

    Area under the plasma concentration versus time curve

  3. Cmax,ss of Metformin

    Time frame: 0-144 hours

    Peak Plasma Concetration at steady-state

  4. AUCτ,ss of Metformin

    Time frame: 0-144 hours

    Area under the plasma concentration versus time curve at Tau, steady-state

Secondary outcomes

  1. Tmax of DWP 16001, Metformin, DWP16001 Metabolites

    Time frame: 0-144 hours

    Time at Cmax

  2. AUC of DWP 16001, Metformin, DWP16001 Metabolites

    Time frame: 0-144 hours

    Area under the plasma concentration versus time curve

  3. T1/2 of DWP 16001, Metformin

    Time frame: 0-144 hours

  4. CL/F of DWP 16001, Metformin

    Time frame: 0-144 hours

    Apparent total clearance of the drug from plasma after oral administration

  5. fe of DWP 16001, DWP16001 Metabolites

    Time frame: 0-72 hours

    Fraction of the drug excreted into the urine

  6. CLR of DWP 16001

    Time frame: 0-144 hours

    Renal clearance of the drug from plasma

Sponsors and collaborators

Lead sponsor

Daewoong Pharmaceutical Co. LTD.

Industry

Registry information

Official study title

A Randomized, Open Label, Single / Multiple Dose, Crossover Phase 1, Study to Evaluate Drug-Drug Interaction of DWP16001 in Combination With Metformin in Healthy Male Adults

Important dates

Study start
2019
Primary completion
2019
Study completion
2019
First posted
Aug 21, 2019
Registry last updated
Jan 13, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.